U.S. patent application number 16/293745 was filed with the patent office on 2019-06-27 for bone marrow harvesting device and storage methods.
The applicant listed for this patent is Stryker European Holdings I, LLC. Invention is credited to Robin Buescher, Roman Nassutt, Nils Reimers.
Application Number | 20190192172 16/293745 |
Document ID | / |
Family ID | 55697500 |
Filed Date | 2019-06-27 |
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United States Patent
Application |
20190192172 |
Kind Code |
A1 |
Nassutt; Roman ; et
al. |
June 27, 2019 |
Bone Marrow Harvesting Device And Storage Methods
Abstract
Bone harvesting tools and methods of use thereof are disclosed.
In an embodiment, the tool comprises a chamber having a first
aperture, a second aperture, an internal cavity, and a suction
source fluidly connected with the chamber. The suction source is
effective to generate negative pressure within the internal cavity
of the chamber. The tool also has a reamer having a reaming
portion, the reamer being sized to extend through the first and
second apertures of the chamber, wherein the reamer is movable
relative to the chamber. Additionally, the tool includes a storage
container fluidly connected to the internal cavity of the chamber
and effective to receive bone and/or cellular material extracted
from the patient, the bone and/or cellular material being extracted
during reaming a bone of the patient with the reamer.
Inventors: |
Nassutt; Roman; (Kiel,
DE) ; Buescher; Robin; (Heikendorf, DE) ;
Reimers; Nils; (Kiel, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Stryker European Holdings I, LLC |
Kalamazoo |
MI |
US |
|
|
Family ID: |
55697500 |
Appl. No.: |
16/293745 |
Filed: |
March 6, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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15078630 |
Mar 23, 2016 |
10231743 |
|
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16293745 |
|
|
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62137521 |
Mar 24, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/164 20130101;
A61B 17/1635 20130101; A61B 2217/005 20130101; A61B 17/1659
20130101; A61B 2017/00969 20130101; A61B 2017/00473 20130101; A61B
10/025 20130101; A61B 2010/0258 20130101; A61B 2017/320064
20130101 |
International
Class: |
A61B 17/16 20060101
A61B017/16; A61B 10/02 20060101 A61B010/02 |
Claims
1. A bone harvesting tool for extraction of bone and/or cellular
material from a patient during a surgical procedure, the tool
comprising: a chamber having a first aperture, a second aperture,
and an internal cavity; a suction source fluidly connected to the
chamber to generate negative pressure within the internal cavity; a
reamer having a reaming portion, the reamer being sized to extend
through the first and second apertures and being movable relative
to the chamber; and a storage container fluidly connected to the
internal cavity of the chamber to receive bone and/or cellular
material extracted during reaming of a bone of the patient with the
reamer.
2. The bone harvesting tool of claim 1, further comprising a first
seal disposed within the first aperture and a second seal disposed
within the second aperture, the first seal being spaced apart from
the second seal.
3. The bone harvesting tool of claim 2, wherein the first and
second seals each include an opening sized to receive the
reamer.
4. The bone harvesting tool of claim 3, wherein the opening in the
second seal is substantially the same size as the reamer so as to
establish a fluid-tight seal between the reamer and the second
seal.
5. The bone harvesting tool of claim 1, wherein the storage
container is a handle of the bone harvesting tool that is removable
from the bone harvesting tool.
6. The bone harvesting tool of claim 5, wherein the storage
container includes a first locking portion and the chamber includes
a second locking portion, the first locking portion of the storage
container being configured to lock with the second locking portion
of the chamber to lock the storage container to the chamber.
7. The bone harvesting tool of claim 1, wherein the storage
container includes a body with a plurality of individual containers
disposed therein, each of the plurality of individual containers
being fluidly isolated from one another.
8. The bone harvesting tool of claim 1, wherein the suction source
is a powered suction source.
9. The bone harvesting tool of claim 1, further comprising a sleeve
projecting outwardly from the chamber, the sleeve including a bone
and/or cellular material channel fluidly connected with the
internal cavity of the chamber.
10. A bone harvesting tool for extraction of bone and/or cellular
material from a patient during a surgical procedure, the tool
comprising: a chamber having a first aperture, a second aperture,
an internal cavity and a suction port adapted to be fluidly
connected to a suction source; a reamer extending through the first
and second apertures and movable relative to the chamber; and a
storage container fluidly connected to the internal cavity to
receive bone and/or cellular material extracted during reaming of a
bone of the patient with the reamer.
11. The bone harvesting tool of claim 10, further comprising a
suction source configured to generate negative pressure within the
internal cavity of the chamber.
12. The bone harvesting tool of claim 11, wherein the suction
source is a powered suction source.
13. The bone harvesting tool of claim 10, wherein the chamber
includes a first seal disposed within the first aperture and a
second seal disposed within the second aperture, the first seal
including a substantially flat surface adapted to create a
fluid-tight seal with skin or tissue of the patient.
14. The bone harvesting tool of claim 13, wherein each of the first
and second seals comprise at least one of a rubber, silicone,
polymer or polymer composite material.
15. The bone harvesting tool of claim 10, wherein the first and
second apertures are diametrically positioned about the chamber
such that the first and second apertures are defined by a common
central axis.
16. The bone harvesting tool of claim 10, wherein the storage
container includes a first locking portion and the chamber includes
a second locking portion, the first locking portion being
coupleable to the second locking portion to removeably connect the
storage container to the chamber.
17. The bone harvesting tool of claim 16, further comprising a
plurality of individual containers disposed within the storage
container, each one of the plurality of individual containers being
fluidly isolated from a remainder of the individual containers.
18. The bone harvesting tool of claim 10, wherein the reamer
includes a proximal portion having a connector configured to couple
the reamer to an instrument for rotating the reamer, and a distal
portion having a tip for reaming bone.
19. The bone harvesting tool of claim 10, wherein the reamer is
cannulated and configured to receive a guide wire.
20. The bone harvesting tool of claim 19, further comprising a
guide wire.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. application Ser.
No. 15/078,630, filed on Mar. 23, 2016, and claims the benefit of
the filing date of U.S. Provisional Patent Application No.
62/137,521, filed Mar. 24, 2015, the disclosures of which are each
hereby incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to devices and methods of
harvesting bone and/or cellular material for use in various medical
treatments.
[0003] The Applicant has devised novel and useful methods for
harvesting bone and/or cellular material in a single-stage
procedure, as described in co-pending U.S. patent application Ser.
No. 14/616,071, titled "Bone Marrow Harvesting and Storage" ("the
'071 Application"), the disclosure of which is incorporated by
reference herein. Particular devices useful for extracting bone
and/or cellular material, in the manner set forth in the '071
Application or otherwise, would be useful, however. The present
invention(s) provides such a device, as well as further extraction
methods.
BRIEF SUMMARY OF THE INVENTION
[0004] A first aspect of the invention includes a bone harvesting
tool for extraction of bone and/or cellular material from a patient
during a surgical procedure. The tool comprises a chamber having a
first aperture, a second aperture, an internal cavity, and a
suction source fluidly connected with the chamber, the suction
source being effective to generate negative pressure within the
internal cavity of the chamber. A reamer having a reaming portion
is also included with the tool, the reamer being sized to extend
through the first and second apertures of the chamber, wherein the
reamer is movable relative to the chamber. Last, the tool has a
storage container fluidly connected to the internal cavity of the
chamber and effective to receive bone and/or cellular material
extracted from the patient, the bone and/or cellular material being
extracted during reaming a bone of the patient with the reamer.
[0005] In an embodiment of the first aspect, the chamber includes a
first seal effective to contact skin and/or tissue of the patient,
and a second seal spaced apart from the first seal. Optionally, the
storage container may be a handle of the bone harvesting tool that
is removable from the bone harvesting tool. The bone harvesting
tool is usable in surgical procedures to obtain and collect bone
marrow, cortical and cancellous bone (e.g., bone chips), and other
bone material for a variety of different medical uses. The tool and
its components are optionally packaged in a sterile package prior
to use (e.g., a single-use sterile package) so that the tool is
easily usable in a surgical procedure involving the drilling of
bone.
[0006] A second aspect of the invention includes a method of
collecting bone and/or cellular material during a surgical
procedure. The method comprises: (a) positioning a bone harvesting
tool having a first seal and a second seal against a patient's skin
and/or tissue so that the first seal establishes a fluid-tight seal
at the location of the patient's skin and/or tissue; (b) operating
a reamer extending through the first and second seals so that a
reaming portion of the reamer drills into a bone of the patient and
creates bone and/or cellular material; (c) generating negative
pressure within an internal cavity of the bone harvesting tool, the
negative pressure causing the bone and/or cellular to flow from the
patient and into the internal cavity; and (d) collecting the bone
and/or cellular material in a storage container removably and
fluidly connected to the internal cavity of the bone harvesting
tool.
[0007] Although the steps above are lettered in the second aspect,
no particular order of the steps is intended or implied by the
lettering. In an embodiment of the second aspect, the method also
comprises identifying a set of patients undergoing an existing
surgical operation in which bone and/or cellular material is to be
removed from the patient, screening the set of patients using
certain criteria to ascertain a subset of patients who qualify to
donate bone and/or cellular material, wherein a first aspect of the
criteria requires the subset of patients to be undergoing an
existing operation in the ordinary course of events, which is not a
surgery dedicated predominantly to extracting the bone and/or
cellular material, and selecting the patient from the subset of
patients and performing steps (a) through (d). The surgical
operation may be an orthopedic operation involving reaming of a
bone of the patient, in particular a medullary canal of the
bone.
[0008] A third aspect of the invention includes a method of
collecting bone and/or cellular material during a surgical
procedure. The method comprises: (a) positioning a bone harvesting
tool having a seal against a patient's skin and/or tissue so that
the seal establishes a fluid-tight seal at the location of the
patient's skin and/or tissue; (b) operating a reamer extending
through the seal so that a reaming portion of the reamer drills
into a bone of the patient and creates bone and/or cellular
material; and (c) generating negative pressure within the bone
harvesting tool, the negative pressure causing the bone and/or
cellular to flow from the patient and into a storage container
removably and fluidly connected to the seal of the bone harvesting
tool.
[0009] Although the steps above are lettered in the third aspect,
no particular order of the steps is intended or implied by the
lettering.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] A more complete appreciation of the subject matter of the
present invention and of the various advantages thereof can be
realized by reference to the following detailed description in
which reference is made to the accompanying drawings in which:
[0011] FIG. 1 is a perspective view of a bone harvesting instrument
according to an embodiment of the present invention;
[0012] FIG. 2 is a close-up exploded perspective view of several
components of the bone harvesting instrument of FIG. 1;
[0013] FIG. 3 is a cross-sectional view of several components of
the bone harvesting instrument of FIG. 1;
[0014] FIG. 4 is a plan view of a bone harvesting system according
to another embodiment of the present invention; and
[0015] FIG. 5 is a partial cross-sectional view of a bone
harvesting system according to yet another embodiment of the
invention.
DETAILED DESCRIPTION
[0016] In describing particular embodiments of the present
invention, specific terminology will be used for the sake of
clarity. However, the invention is not intended to be limited to
any specific terms used herein, and it is to be understood that
each specific term includes all technical equivalents, which
operate in a similar manner to accomplish a similar purpose.
[0017] As used herein, the phrase bone and/or cellular material
refers to material that is extractable from bone, which optionally
may be processed and/or separated to produce another material. For
instance, bone and/or cellular material may include cancellous
bone, cortical bone (in the form of chips or morselized bone), bone
marrow material, or stem cells produced from any of the foregoing
materials. Such materials frequently are found, for example, in the
medullary canal (as well as the bone surrounding the canal) of a
long bone.
[0018] Referring to FIG. 1, a bone harvesting instrument 10 is
shown. Instrument 10 includes a chamber 20, in one embodiment
shaped as a ball or sphere, and a reaming or drilling implement 60
extending through chamber 20. A sleeve 42 extends outwards from
chamber 20, and a suction tube 50 is connected thereto for
providing negative pressure and suction in the vicinity of chamber
20. A storage container 41 is also fluidly connected with chamber
20. In this way, bone harvesting instrument 10 can be used to ream
or drill bone using reamer 60, and extract bone and/or cellular
material therefrom through sleeve 42 and into storage handle 41 for
immediate or later use. Such bone and/or cellular material is
typically in the form of bone marrow material in the intramedullary
canal of the bone being reamed, as well as surrounding cancellous
and cortical bone.
[0019] As shown in FIGS. 1 and 3, chamber 20 is, in an embodiment,
spherical in shape and includes a hollow internal cavity 21.
Apertures 30, 32 extend through chamber 20 and are sized to
accommodate respective first and second sealing members 22, 24.
Sealing members 22, 24 may be roughly cylindrical in shape with
substantially flat ends. As an example, first seal 22 may be
arranged to contact skin and/or tissue of a patient during a
surgical procedure to establish a fluid-tight seal therewith, and
thus, it may have a substantially flat skin/tissue facing surface
34, as shown in FIG. 3. In an embodiment, surface 34 is angled or
tapered, such that the body of first seal 22 has a variable
thickness. First and second seals 22, 24 also include openings 26,
28 sized to accommodate sleeve 42 and reamer 60, respectively, as
shown in FIGS. 1-3. In a particular embodiment, openings 26, 28
each has a center that lies along a common axis, as shown in FIG.
3. Stated alternatively, openings 26, 28 are cylindrical in an
embodiment and, if opening 28 were superimposed within opening 26,
it would form a concentric cylinder within opening 26. This allows
reamer 60 to be inserted into opening 28 and subsequently through
sleeve 42 and opening 26 of first seal 22. Referring to FIG. 3,
seals 22, 24 extend entirely through apertures 30, 32 to
effectively establish a fluid-sealed environment within chamber 20
and thereby allow bone and/or cellular material to be drawn through
chamber 20. First and second seals 22, 24 may be affixed to
apertures 30, 32 through any suitable means, for example via
adhesives, through mating geometries, other bonding techniques, or
a combination of the foregoing. First and second seals 22, 24 may
also be composed of any suitable sealing material, such as rubber,
silicone, or a polymer or polymer composite.
[0020] Referring to FIGS. 2-3, chamber 20 also includes a set of
threaded openings 39, 40. Threaded opening 39 is sized and
configured to accept a connector 38 that, in one embodiment,
includes a fluid channel therethrough. Connector 38 engages with
opening 39 in a manner allowing suction tubing 50 to connect
therewith and establish a fluid channel to a suction source (not
shown). The suction source (not shown) may be either powered or
manual and is effective to create negative pressure in tubing 50
and, consequently, within internal cavity 21 of chamber 20 for
withdrawing bone and/or cellular material out of the patient.
Threaded opening 40 is sized and configured to accept a threaded
end 46 of storage handle 41, as shown in FIGS. 2-3.
[0021] Storage handle 41 includes a hollow cavity 48 for accepting
extracted bone and/or cellular material, and a flange 43 for
abutting against chamber 20 once storage handle 41 is engaged with
chamber 20. By way of threaded end 46 and threaded opening 40,
storage handle 41 can be easily disengaged from chamber 20 after
the surgical procedure is complete and all bone and/or cellular
material is within handle 41. Of course, other connection
mechanisms are contemplated between handle 41 and chamber 20, such
as a press-fit connection, bayoneted connection, or any other
suitable locking or engagement mechanism.
[0022] As shown in FIGS. 1-2, instrument 10 may also include a
drill or reamer 60. Reamer 60 has a shaft 64 that is sized to
extend through opening 28 in second seal 24, into internal cavity
21 of chamber 20, and into and through sleeve 42 and first seal 22
housing sleeve 42. A distal end or portion of reamer 60 includes a
reaming or drilling portion 62 that is optionally fluted. Further,
shaft 64 of reamer 60 may be cannulated to allow a guide wire 70
(e.g., a K-wire) to be positioned therein. Shaft 64 is also
flexible, in an embodiment, to permit directional movement of
reamer 60 and its reaming end 62 during drilling. Reamer 60
additionally includes a proximal end or portion with a connection
66 for engaging with a powered or manual instrument (not shown) for
rotating reamer 60 and drilling bone. In an embodiment, connection
66 may be keyed for insertion into a likewise keyed portion of the
powered or manual instrument (not shown). As reflected in FIG. 3,
shaft 64 of reamer 60 may be roughly the same size (e.g., in terms
of diameter) as opening 28 in second seal 24 to establish a
fluid-tight seal at that location, but shaft 64 may be
substantially smaller in size (e.g., in terms of diameter) than
sleeve 42 to allow bone and/or cellular material to pass over shaft
64, into sleeve 42, and subsequently through internal cavity 21 of
chamber 20 and into handle 41.
[0023] In use, instrument 10 may extract bone and/or cellular
material from a patient undergoing a surgical operation, for
instance an already-scheduled surgical operation in the normal
course of events. In this regard, instrument 10 may be used to
practice any of the methods disclosed in Applicant's '071
Application, and thus, it may be used to collect bone and/or
cellular material in a surgical procedure where standard operating
procedure is to discard such material. Of course, instrument 10 may
also be used in other surgical procedures, including procedures
dedicated solely to the extraction of bone and/or cellular
material.
[0024] Using the methods of the '071 Application as an example,
instrument 10 may be used in an intramedullary (IM) nail procedure
being conducted on a patient. During such a procedure, the bone
and/or cellular material generated is normally discarded. However,
using instrument 10, such bone and/or cellular material can be
stored for further processing and use at a later time, for example
as set forth in the `071 Application. In an embodiment, the surgeon
may conduct the procedure by first making an appropriate
incision(s) through the patent's skin and issue to access the
surgical site (e.g., an intramedullary canal of a long bone), and
then insert a K-wire 70 into the patient's bone to provide a path
for reaching the surgical site. The surgeon may then position
instrument 10 against the patient's skin. In particular, with the
components of instrument 10 assembled, as shown in FIG. 1 (e.g.,
handle 41 connected to chamber 20, tube 50 engaged with connector
38, seals 22, 24 and sleeve 42 in place, and reamer 60 extending
through chamber 20), reamer 60 may be positioned over K-wire 70 and
moved towards the patient's bone for reaming. K-wire 70 may guide
reamer 60 and sleeve 42 through the patient's skin and tissue until
sleeve 42 extends therethrough and reamer 60 is adjacent the bone
to be reamed. In this way, sleeve 42 may establish a channel
leading into internal cavity 21 of chamber 20 for extraction of
bone and/or cellular material.
[0025] Skin/tissue facing surface 34 of first seal 22 may also be
placed against the patient's skin/tissue to establish a fluid-tight
seal at that location. Such a fluid-tight seal effectively allows
instrument 10 to maintain negative pressure within chamber 20 and
not loose pressure at the location of the patient's skin/tissue. In
an embodiment, first seal 22 may sit atop the patient's skin around
the incision site, or it may be embedded somewhat below the
patient's skin in tissue. In a modification, first seal 22 may be
placed within the patient's tissue and against the bone being
reamed to establish an effective seal. In any of the above cases, a
fluid-tight seal is created via first seal 22 at the relevant
location for creating a closed environment in instrument 10.
[0026] With instrument 10 in position, reaming of the patient's
bone may take place using reamer 60, in particular its reaming
end/portion 62. The surgeon may direct reaming end/portion 62
within the intramedullary canal of a patient's long bone (or the
intramedullary canal of another bone) and, during the reaming
process, bone and/or cellular material may be extracted. In
particular, as the bone is reamed, negative pressure may be
generated within internal cavity 21 of chamber 20 by way of
connector 38, suction tube 50, and a manual or powered suction
source (not shown). The negative pressure causes the bone and/or
cellular material to exit the patient's intramedullary canal,
travel into sleeve 42, into internal cavity 21 of chamber 20, and
subsequently into storage handle 41. In this way, the extracted
bone and/or cellular material never reaches the external
environment and, rather, it is kept in a sterile environment and
stored in storage handle 41. Indeed, in an embodiment, all of
instrument 10's components may be packaged in a single-use sterile
package so that such components are easily usable in the surgical
procedure and the components do not adversely affect the quality or
usability of the extracted bone and/or cellular material (e.g.,
since the components are pre-sterilized). As such, with the
aforementioned procedure, the bone and/or cellular material is
extracted from the patient and stored in storage handle 41, which
may be of any suitable size, for later use or further processing.
In an embodiment, a cap (not shown) is also provided with
instrument 10 for sealing off and closing handle 41 once the bone
and/or cellular material is collected therein.
[0027] As discussed in the '071 Application, the bone and/or
cellular material extracted by instrument 10 can also be sent to a
storage, separation, and processing facility (e.g., a "biobank")
for use in a later surgical procedure involving the patient, or a
different patient. The extracted bone and/or cellular material can
be processed at the biobank and used in a multitude of different
medical procedures, as set forth in more detail in the '071
Application. For example, the biobank may process the material to
obtain stem cells for the patient's later use (or use by another,
qualifying patient). It should be appreciated that any of the uses
described in the '071 Application for bone and/or cellular material
are applicable to the bone and/or cellular material discussed
herein, including but not limited to use as stem cells, allograft
material, autograft material, and other uses.
[0028] In a modification of the above, storage handle 41 may
comprise separate individual containers for different uses of the
bone and/or cellular material. As an example, storage handle 41 may
comprise three (3) individual containers for bone and/or cellular
material, a first container for typification of the donator (e.g.,
to determine blood type, etc.), a second container for
safety/quality examination, and a third main container for
cryogenic storage of the bone and/or cellular material (e.g., stem
cells) for later use with that patient, or a different patient. In
this way, instrument 10 can provide a convenient means of
accumulating all the necessary materials needed for proper banking
of the bone and/or cellular material for later use. In one
embodiment, the three (3) separate containers are initially joined
together, but can be detached and used for their separate purposes,
as described above. In yet another embodiment, a valve(s) may be
used to direct the extracted bone and/or cellular material into the
desired three (3) individual containers, and a transparent level
with volume markings may be included on storage handle 41 for
determining the amount of material in each container. For example,
the surgeon may use the valve(s) to direct bone and/or cellular
material into the first container within storage handle 41 until
the volume thereof is at an acceptable level (e.g., as determined
by the transparent level with volume markings), and then the
valve(s) could be actuated to direct the remainder of the bone
and/or cellular material into the other containers, at the
discretion of the surgeon (e.g., again by using the transparent
level with volume markings for each container).
[0029] At the completion of the reaming process, storage handle 41
may be easily removed from chamber 20 and labeled with any
appropriate labels for further storage or processing of the
material (e.g., at the biobank). Instrument 10 therefore provides a
suitable means for collecting bone and/or cellular material during
standard procedures in a sterile way, where such biologic materials
are normally discarded.
[0030] In an optional embodiment, instrument 10 also includes a
filter or mesh positioned in fluid communication with storage
handle 41 so that the material extracted from the patient/donor can
be filtered, as necessary. The filter or mesh allows instrument 10
to extract material that only meets certain defined criteria (e.g.,
particular sized bone chips, morsels, and/or marrow). In one
example, each of the individual containers within storage handle 41
may include their own filters or meshes.
[0031] An alternate embodiment of a bone harvesting system 100 is
shown in FIG. 4. Harvesting system 100 includes a collection bag
120 for storing extracted bone and/or cellular material, and a
manual suction device 130 (e.g., a syringe) for causing the bone
and/or cellular material to move into collection bag 120.
Alternatively, a powered suction device (not shown) could be used.
A tube 110 is fluidly connected to collection bag 120 for moving
bone and/or cellular material into bag 120. Tubing 110 leads into a
multi-way valve 122 (e.g., a three-way valve), shown schematically
in FIG. 4, which is effective to fluidly connect tube 110 to one of
a number of pouches 124 within bag 120. Pouches 124 may be used to
store bone and/or cellular material for different purposes (e.g., a
pouch 124 for typification of the donor, a pouch 124 for testing
the quality of the bone and/or cellular material, and a main
storage pouch 124). As above, filters or meshes may be associated
with each pouch 124 for filtering of the bone and/or cellular
material.
[0032] In use, the surgeon may connect tube 110 to an instrument
for reaming bone (not shown) or directly to the intramedullary
canal of a patient's bone. During the reaming process, the surgeon
may actuate suction device 130 to generate negative pressure in
tube 110 and cause the bone and/or cellular material generated
during the reaming process to move into tube 110 and subsequently
to multi-way valve 122. At the surgeon's election, multi-way valve
is then positioned in one of a number of locations, causing the
extracted bone and/or cellular material to be deposited in one of
pouches 124 within bag 120. In this manner, bone and/or cellular
material may be extracted from a patient and positioned in bag 120
in a sterile manner. Indeed, as shown in FIG. 4, all of the
components of bone harvesting system 100 may be placed in a
single-use sterile package 140 for use by the surgeon in a sterile
manner. Again, as above, it is to be understood that bone
harvesting system 100 may be used in any of the methods disclosed
in Applicant's '071 Application.
[0033] Yet another embodiment of a bone harvesting system 200 is
shown in FIG. 5. As the embodiment shares commonalities with bone
harvesting system 100, like numerals refer to like elements in this
embodiment, but numbered in the 200s instead of the 100s.
[0034] Bone harvesting system 200 includes a collection bag 220
with a series of pouches 224 (e.g., three) therein, and a tube 210
fluidly connecting bag 220 to an instrument for reaming bone. As
above, tube 210 may lead into a multi-way valve (e.g., a three-way
valve, not shown) for diverting bone and/or cellular material into
each of pouches 224. Filters or meshes may also be fluidly
connected to each pouch 224 for filtering bone and/or cellular
material.
[0035] Bone harvesting system 200 includes a sealing cover 250,
optionally made of silicone, rubber, a polymer, or a polymer
composite material suitable for creating a fluid-tight seal at the
location of the patient's skin or tissue. Cover 250 has an opening
252 sized to receive a drill or reamer 260 therethrough, as shown
in FIG. 5. As can be appreciated, opening 252, in an embodiment, is
sized to be only slightly larger in diameter than the size of
reamer 260 so as to allow a fluid-tight area to be maintained
within sealing cover 250 during the reaming process. In a
particular embodiment, reamer 260 may itself include a seal (not
shown) that interacts with opening 252 and allows rotation of
reamer relative to the seal to ensure a fluid-tight area is
maintained within sealing cover 250 during reaming.
[0036] Sealing cover 250 also includes a set of legs 254, 256
extending from its body and arranged to contact the skin and/or
tissue of a patient during the reaming process, as shown in FIG. 5.
Legs 254, 256 are effective to establish and maintain a fluid-tight
seal at the location of the patient's skin and/or tissue so that
negative pressure generated within sealing cover 250 during the
operation is maintained and reaming and extraction of bone and/or
cellular material can proceed effectively. In an embodiment, legs
254, 256 may include a mild adhesive for adhering legs 254, 256 to
the patient's skin and/or tissue during the operation to improve
the quality of the seal.
[0037] In a further embodiment, sealing cover 250 also includes a
tube or sleeve 258 extending from its body and into the incision
site to establish a path for the bone and/or cellular material of
the patient to travel. In an exemplary embodiment, sleeve 258
includes a flange at its end for engaging soft tissue and/or bone
and securing sealing cover 250 relative thereto. Although not
shown, a suction source is placed in fluid communication with bag
220 and/or sealing cover 250 to create negative pressure within
sealing cover 250 and consequently draw bone and/or cellular
material out of the patient and into bag 220.
[0038] In use, bone collection system 200 operates similar to the
previous embodiments. A surgeon creates an initial incision in the
patient and uses a guide wire to create a path to the bone to be
reamed (e.g., a long bone). Reamer 260, which is cannulated in an
embodiment, may then proceed over the guide wire and assist with
directing sealing cover 250 attached thereto adjacent the patient's
skin and/or tissue. The surgeon then docks sealing cover 250
against the patient's skin and/or tissue to create a fluid-tight
seal at that location. Legs 254, 256 of sealing cover 250 are
effective to assist in creating this seal. Further, in an
embodiment, sleeve 258 extends through the patient's skin and
tissue and adjacent the patient's bone. The surgeon may then ream
the bone using reamer 260 and, as a consequence of the negative
pressure created by the suction source (not shown), bone and/or
cellular material generated during the reaming process may travel
into sealing cover 250 and subsequently into pouches 224 of bag
220. The multi-way valve (not shown) may be used to direct bone
and/or cellular material into each of the individual pouches 224,
at the surgeon's discretion. Subsequently, if desired, pouches 224
may be closed off and individually separated from bag 220 (e.g., by
pre-formed perforations) so that each pouch 224 may be used for its
dedicated purpose (e.g., a pouch 224 for typification, a pouch 224
for quality control, and a pouch 224 for main storage). Of course,
more or less pouches 224 may be included with bag 220 for other
purposes.
[0039] Although the invention herein has been described with
reference to particular embodiments, it is to be understood that
these embodiments are merely illustrative of the principles and
applications of the present invention. It is therefore to be
understood that numerous modifications may be made to the
illustrative embodiments and that other arrangements may be devised
without departing from the spirit and scope of the present
invention as defined by the appended claims.
[0040] It is also to be understood that individual features
described in connection with certain embodiments can be shared with
other embodiments, to the extent feasible. Further, the features of
certain claims can also be shared with other claims, in any
combination.
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